NA 357.369Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10886982196033), received between Jan 16, 2017 and May 3, 2022 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (14 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE TFN SLEEVE INNER TUB SEAMS OFF THEREFORE THE INSERTION SHAFT DOESN'T SLID PROPERLY. THIS COMPLAINT INVOLVES ONE (1) DEVICE GUIDE SLEEVE F/HELICAL BLADE F/TFN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14270339 ↗
• MalfunctionFeb 28, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6), 2022, DURING A PROCEDURE THE SURGEON INSERTED THE BLADE/SLEEVE INTO THE AIMING ARM AND PUSHED IN THE BUTTRESS/COMPR-NUT F/357.369 AND GUIDE SLEEVE F/HELICAL BLADE F/TFN IN TO THE AIM-ARM F/TFN 130°, WHICH POPPED OUT OF THE AIMING ARM THREE(3) TIMES. ANOTHER SET WAS OPENED UP AND THE CASE WAS FINISHED WITH NO ISSUES. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF THREE(3) MINUTES. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) BLD GUIDE SLEEVE FOR TFN. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13621280 ↗
• MalfunctionOct 20, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY OF PROXIMAL FEMUR OSTEOSYNTHESIS WITH THE TFN SYSTEM. AT THE TIME OF THE PLACEMENT OF THE GUIDE SHEATH FOR THE SPIRAL BLADE, IT WAS NOT FULLY FUNCTIONING. THE GUIDE SEPARATED FROM THE CORTEX AND IN THE SAME WAY GIVING A NOT SO EXACT MEASUREMENT OF THE SPIRAL BLADE TO BE PLACED. THE PROCEDURE TERMINATED WITH NO GREATER IMPACT TO THE PATIENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12665072 ↗
• MalfunctionMar 12, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2021, THE BLADE GUIDE SLEEVE WAS NOT STRAIGHT. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11475644 ↗
• MalfunctionNov 16, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, THE DAY AFTER THE TROCHANTERIC FIXATION NAIL ADVANCED (TFN) PROCEDURE, STERILE PROCESSING DEPARTMENT (SPD) INFORMED THE SALES CONSULTANT OF THE BUTTRESS/COMPRESSION NUT BEING STUCK TO THE GUIDE SLEEVE FOR HELICAL BLADE. IT WAS LIKELY PRESSED DOWN TOO MUCH DURING THE PROCEDURE AND SPD COULD NOT REMOVE IT BEFORE OR AFTER BEING WASHED. IT CANNOT BE REMOVED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10848880 ↗
• MalfunctionNov 10, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING A PROXIMAL FEMUR OSTEOSYNTHESIS USING AN INTERTROCHANTERIC NAIL, AT THE TIME OF PLACING THE SPIRAL BLADE, THE SURGEON USED THE HAMMER FOR IMPACTIONS WHICH CAUSED THE HEAD OF THE CONNECTING SCREW TO BREAK. THE SURGEON WAS UNABLE TO REMOVE THE SCREW FROM THE BLADE AND DECIDED TO REMOVE THE BLADE AGAIN BY HITTING THE INSERTION ARC. THE BLADE WAS REMOVED AND THE PROCEDURE WAS CONTINUED. THE ARCH WIRE WAS ALREADY DAMAGED BY THE IMPACTIONS. THE DRILL GUIDE WAS PLACED FOR THE DISTAL LOCKING OF THE NAIL, AND THIS HOLE THROUGH WHICH THE DRILL GUIDE SLEEVE PASSES IS NOT IN GOOD CONDITION. THE SLEEVE ENTERED THE HOLE AND THE DRILLING WAS MADE FOR THE DISTAL LOCKING OF THE NAIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICES REPORTED: UNKNOWN TFN NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN HAMMER (PART # UNKNOWN LOT # UNKNOWN, QUANTITY 1), UNKNOWN TFN HELICAL BLADE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), UNKNOWN HAMMER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) BLADE GUIDE SLEEVE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10818070 ↗
• MalfunctionOct 6, 2020Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, THE GUIDE FOR THE SPIRAL BLADE WAS DAMAGED, THE GUIDE GOT STUCK AND SINCE THE ROD HAD TO PASS THROUGH THE CANAL, BUT IT WAS NOT POSSIBLE BECAUSE THE SPIRAL WAS DAMAGED. THIS CAUSED DELAY OF APPROXIMATELY TWENTY (20) MINUTES. THERE WAS ANOTHER BOX WITH STERILE INSTRUMENTS AT THE INSTITUTION, SO THIS WAS USED IN SURGERY. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10635816 ↗
• MalfunctionAug 28, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE COMPRESSION NUT (357.69) IS JAMMED ON THE SLEEVE (357.371). CONCOMITANT DEVICES: UNKNOWN NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN AIMING ARM (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR 1 BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10467409 ↗
• MalfunctionJun 11, 2020Device-Device Incompatibility; Device-Device Incompatibility

  CONCOMITANT DEVICE REPORTED: IMPACTION INST: HAMMER/MALLET: TRAUMA (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1); BUTTRESS/COMPRESSION NUT FOR 357.369 (PART #: 357.371, LOT #: 4987428, QUANTITY: 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10146057 ↗
• MalfunctionNov 13, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING ROUTINE INCOMING INSPECTION, THE GUIDE SLEEVE FOR HELICAL BLADE FOR TROCHANTERIC FEMUR NAIL (TFN) WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9316420 ↗
• MalfunctionSep 20, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A TROCHANTERIC FEMORAL NAIL PROCEDURE, THE LOCKING MECHANISM THAT ROTATIONALLY LOCKS THE HELICAL BLADE OR LAG SCREW FELL DOWN INTO THE NAIL DURING THE OPERATION BEFORE IT WAS SUPPOSED TO. THE FOLLOWING ARE THE DEVICES USED DURING THE INSERTION OF THE HELICAL BLADE: UNKNOWN HELICAL BLADE INSERTION HANDLE, UNKNOWN CONNECTING SCREW, AIMING ARM, OUTER SLEEVE THROUGH THE AIMING ARM. WHILE INSERTING THE HELICAL BLADE, THE BLADE GOT STUCK HALFWAY BETWEEN FULLY INSERTED AND COMING OUT, AND UNABLE TO EXTRACT THE HELICAL BLADE OR ADVANCE IT FORWARD BECAUSE IT¿S A LITTLE TOO IN THE LOCKING MECHANISM BROKE OFF AND GOT LEDGE IN BETWEEN THE HELICAL BLADE AND THE NAIL ITSELF IN THE MIDDLE. THERE WAS A BACKUP DEVICE USED, THE NAIL AND HELICAL BLADE WERE REMOVED AND A NEW NAIL AND BLADE WERE USED. THERE WAS A DIFFICULTY IN THE REMOVAL. THE DOCTOR ATTEMPTED TO USE STANDARD TFN EXTRACTION INSTRUMENTATION BUT WAS UNSUCCESSFUL AS THE HELICAL BLADE WAS NOT ABLE TO BE REMOVED INDEPENDENTLY FROM THE NAIL. EVENTUALLY, HE EXTRACTED BOTH THE NAIL AND BLADE OUT TOGETHER. THE FOLLOWING ARE THE DEVICES USED IN THE CASE BUT ARE UNABLE TO DISASSEMBLE THEM

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9099993 ↗
• MalfunctionMay 23, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019. DURING AN UNKNOWN PROCEDURE, THE HELICAL BLADE INSERTER WOULD NOT FIT THROUGH THE BLADE GUIDE SLEEVE. THEY COULD NOT FIGURE OUT WHICH PIECE CAUSED THE ISSUE. THE BLADE GUIDE SLEEVE MIGHT HAVE HAD THE HOLES AT THE WRONG SPOT OR IT COULD HAVE BEEN DAMAGED ON THE HELICAL INSERTER. THE SURGEON USED A FREE HAND TO INSERT THE BLADE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8636925 ↗
• MalfunctionApr 10, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAIL DID NOT ALLOW THE TROCARS AND HELICAL BLADE INSERTERS TO EASILY PASS THROUGH IT. THE DEVICE HAD BEEN INSPECTED AND REPLACED. IT IS UNKNOWN IF THERE WAS PROCEDURE OR PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN - INSERTION INSTRUMENTS: TROCAR: TR(PART#UNKNOWN, LOT#UNKNOWN, QUANTITY#UNKNOWN); UNKNOWN HELICAL BLADE INSERTERS (PART#UNKNOWN, LOT#UNKNOWN, QUANTITY#UNKNOWN). THIS REPORT IS FOR ONE (1) BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8499806 ↗
• MalfunctionMar 7, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING POST-OPERATIVE INSPECTION ON (B)(6) 2019, THE BLADE GUIDE SLEEVE AND COMPRESSION NUT WERE DISCOVERED TO BE STUCK TOGETHER. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8400511 ↗
• MalfunctionNov 20, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2018, HELICAL BLADE INSERTER TOP SCREW (CONNECTING SCREW) IS NOT FUNCTIONING PROPERLY. IN ADDITION, THE BUTTRESS/COMPRESSION NUT DOES THREAD PROPERLY ON A BLADE GUIDE SLEEVE THREAD. THE ISSUES OCCURRED DURING AN UNKNOWN PROCEDURE. THIS REPORT IS FOR ONE (1) BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8089775 ↗
• MalfunctionOct 1, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2018, DURING AN UNKNOWN PROCEDURE, THE BLADE GUIDE SLEEVE FOR A TROCHANTERIC FIXATION NAILS WAS STUCK IN THE 130 DEGREE AIMING ARM FOR TROCHANTERIC FIXATION NAILS. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7921928 ↗
• MalfunctionJul 18, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING A PRE-INSERTION TESTING OF THE TROCHANTERIC FIXATION NAIL (TFN) NAIL, THAT THE DEVICES WERE NOT ALIGNING CORRECTLY. THE NAIL WAS CONNECTED TO THE INSERTION HANDLE, THEN THE AIMING ARM WAS ATTACHED ALONG WITH THE COMPRESSION NUT AND SLEEVES FOR A WIRE. IT WAS NOTICED THAT THE BUTTRESS COMPRESSION NUT AND AIMING ARM WERE MISALIGNED WITH THE NAIL. THE AIMING ARM WAS REMOVED AND A NEW SET WAS OPENED WHERE THE ALIGNMENT WAS ACCURATE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. CONCOMITANT DEVICE: INSERTION HANDLE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1) THIS REPORT IS FOR A BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7698333 ↗
• MalfunctionMay 9, 2017Mechanical Jam; Mechanical Jam

  CONCOMITANT DEVICES REPORTED: CONNECTING SCREW FOR RADIOLUCENT INSERTION HANDLE (PART # 03.010.474, LOT # 8991929, QUANTITY 1).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6554942 ↗
• MalfunctionApr 29, 2017Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING AN INITIAL SURGERY TO TREAT A HIP FRACTURE WITH TROCHANTERIC FIXATION NAIL (TFN) IMPLANTS ON (B)(6) 2017, THE WIRE GUIDE WOULD NOT GO THROUGH THE BLADE GUIDE SLEEVE ALL THE WAY AND THE HELICAL BLADE INSERTER IS STUCK INSIDE OF THE BLADE GUIDE SLEEVE. WHILE ASSEMBLING THE TRIPLE TROCAR ASSEMBLY WHICH CONSISTED OF THE BLADE GUIDE SLEEVE, WIRE GUIDE, TROCAR, AND BUTTRESS/COMPRESSION NUT, AT THE BACK TABLE, THE SURGICAL TECHNICIAN NOTICED THAT THE WIRE GUIDE WOULD ONLY GO HALF WAY IN THE BLADE GUIDE SLEEVE. UPON INSPECTING THE OUTSIDE OF THE BLADE GUIDE SLEEVE, IT APPEARS THAT IT HAS TAKEN A COUPLE OF HITS BY A MALLET IN THE PAST. A BACKUP TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) SET WAS AVAILABLE HOWEVER, SURGEON DECIDED TO MOVE AHEAD WITH THE CASE USING THE TWO DEVICES TO PREVENT ANY SURGICAL DELAYS. THE DEVICES WERE SUCCESSFULLY USED WITH THE AIMING ARM (CONCOMITANT) AND INSERTION HANDLE (CONCOMITANT). WHEN REMOVING THE WIRE GUIDE AND BLADE GUIDE SLEEVE DURING SURGERY, THE WIRE GUIDE WAS JAMMED IN THE BLADE GUIDE SLEEVE. A TWO TO THREE SECONDS SURGICAL DELAY WAS NOTED DUE TO REMOVING THE DEVICES USING A PAIR OF PLIERS. AFTER THE HELICAL BLADE WAS SUCCES

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6532474 ↗
• MalfunctionApr 19, 2017Sticking; Sticking

  IT WAS REPORTED THAT DURING A TROCHANTERIC FIXATION NAIL (TFN) PROCEDURE ON (B)(6) 2017, THE BLADE GUIDE SLEEVE WAS STICKING IN THE 130 DEGREE AIMING ARM, MAKING IT DIFFICULT TO DISENGAGE THE BLADE GUIDE SLEEVE FROM THE AIMING ARM. SURGEON HAD TO UNSCREW THE AIMING ARM TO PULL THE BLADE GUIDE SLEEVE OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR ONE (1) BLADE GUIDE SLEEVE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6505354 ↗
• MalfunctionFeb 3, 2017Failure to Align; Failure to Align

  UPDATE: CONCOMITANT DEVICE REPORTED: AIMING ARM (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1).

  Patient problems: No Patient Involvement

  MAUDE report 6300009 ↗
• MalfunctionJan 16, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT AN INITIAL TROCHANTERIC FIXATION NAIL (TFN) PROCEDURE FOR THE LEFT FEMUR TOOK PLACE ON (B)(6) 2016 WHERE SEVERAL DEVICE MALFUNCTIONS OCCURRED. THE HELICAL BLADE COUPLING SCREW BROKE INTO TWO PIECES WHILE BEING HAMMERED BY AN UNKNOWN MALLET. THOSE PIECES WERE RETRIEVED WITH DIFFICULTY AND UNSPECIFIED ADDITIONAL INTERVENTION RESULTING IN A THIRTY (30) MINUTE SURGICAL DELAY. ADDITIONALLY, AS THE HELICAL BLADE INSERTER WAS REMOVED IT WAS NOTED THE TIP WAS BROKEN IN PIECES AS A RESULT FROM THE HAMMERING. ALL PIECES WERE RETRIEVED FROM THE BROKEN INSERTER. IT WAS ALSO DETERMINED THE THREADS OF THE BLADE GUIDE SLEEVE BECAME DAMAGED WHILE THE SURGEON WAS TRYING TO REMOVE THE HELICAL BLADE INSERTER. THE BUTTRESS COMPRESSION NUT FOR THE BLADE GUIDE SLEEVE COULD NO LONGER BE TURNED, AND WAS NO LONGER USABLE BECAUSE OF THE DAMAGE TO THE THREADS. THIS PUSHED THE BLADE GUIDE SLEEVE INTO THE 130 DEGREES AIMING ARM. THE BUTTRESS COMPRESSION NUT AND THE BLADE GUIDE SLEEVE BECAME STUCK TOGETHER. DURING THE IMPLANTATION OF THE HELICAL BLADE AND THE NAIL THE SURGEON REPORTED DIFFICULTY IN IMPLANTING THE TWO DEVICES. A PAIR OF NON-SYNTHES PLIERS WAS USED TO REMOVE THE HELICAL BLADE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6254126 ↗